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Commission Directive 96/77/EC 1996L0077 — EN — 29.12.1998 — 001.001 — 1 This document is meant purely as documentation tool and the institutions do not assume any liability for its contents "B COMMISSION DIRECTIVE 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) (OJ L 339, 30.12.1996, p. 1) Amended by: Official Journal No page date "M1 Commission Directive 98/86/EC of 11 November 1998 L 334 1 9.12.1998 1996L0077 — EN — 29.12.1998 — 001.001 — 2 !B COMMISSION DIRECTIVE 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (1), as amended by European Parliament and Council Directive 94/34/EC (2), and in particular Article 3 (3) (a) thereof, After consulting the Scientific Committee for Food, Whereas it is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (3); Whereas it is necessary to replace the purity criteria set out in Council Directive 65/66/EEC of 26 January 1965 laying down specific criteria of purity for preservatives authorized for use in foodstuffs intended for human consumption (4), as last amended by Directive 86/604/EEC (5); Whereas it is necessary to replace the purity criteria set out in Council Directive 78/664/EEC of 25 July 1978 laying down specific criteria of purity for antioxidants which may be used in foodstuffs intended for human consumption (6), as amended by Directive 82/712/EEC (7); Whereas Directives 65/66/EEC and 78/664/EEC should be repealed accordingly; Whereas it is necessary to take into acount the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (Jecfa); Whereas food additives, if prepared by production methods or starting materials significantly different from those included in the evaluation of the Scientific Committee for Food, or if different from those mentioned in this Directive, should be submitted for evaluation by the Scientific Committee for Food for the purposes of a full evaluation with emphasis on the purity criteria; Whereas, the measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Foodstuffs, HAS ADOPTED THIS DIRECTIVE: Article 1 The purity criteria referred to in Article 3 (3) (a) of Directive 89/107/EEC for food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in the Annex hereto. !M1 Article 2 The purity criteria referred to in Article 1 replace the purity criteria set out in Directives 65/66/EEC, 78/663/EEC and 78/664/EEC. (1) OJ No L 40, 11. 2. 1989, p. 27. (2) OJ No L 237, 10. 9. 1994, p. 1. (3) OJ No L 61, 18. 3. 1995, p. 1. (4) OJ No 22, 9. 2. 1965, p. 373. (5) OJ No L 352, 13. 12. 1986, p. 45. (6) OJ No L 223, 14. 8. 1978, p. 30. (7) OJ No L 297, 23. 10. 1982, p. 31. 1996L0077 — EN — 29.12.1998 — 001.001 — 3 !B Article 3 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive before 1 July 1997. They shall immediately inform the Commission thereof. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. 2. Products put on the market or labelled before 1 July 1997 which do not comply with this Directive may be marketed until stocks are exhausted. Article 4 This Directive shall enter into force on the 20th day following that of its publication in the Official Journal of the European Communities. Article 5 This Directive is addressed to the Member States. 1996L0077 — EN — 29.12.1998 — 001.001 — 4 !B ANNEX E 200 SORBIC ACID Definition Chemical name Sorbic acid Trans, trans-2,4-hexadienoic acid Einecs 203-768-7 Chemical formula C6H8O2 Molecular weight 112,12 Assay Content not less than 99 % on the anhydrous basis Description Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 °C Identification A. Melting range Between 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator B. Spectrometry An isopropanol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm C. Positive test for double bonds D. Sublimation point 80 °C Purity Water content Not more than 0,5 % (Karl Fischer method) Sulphated ash Not more than 0,2 % Aldehydes Not more than 0,1 % (as formaldehyde) Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 202 POTASSIUM SORBATE Definition Chemical name Potassium sorbate Potassium (E,E)-2,4-hexadienoate Potassium salt of trans, trans 2,4-hexadienoic acid Einecs 246-376-1 Chemical formula C6H7O2K Molecular weight 150,22 Assay Content not less than 99 % on the dried basis Description White crystalline powder showing no change in colour after heating for 90 minutes at 105 °C Identification A. Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator 1996L0077 — EN — 29.12.1998 — 001.001 — 5 !B B. Positive tests for potassium and for double bonds Purity Loss on drying Not more than 1,0 % (105 °C, 3h) Acidity or alkalinity Not more than about 1,0 % (as sorbic acid or K2CO3) Aldehydes Not more than 0,1 %, calculated as formaldehyde Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 203 CALCIUM SORBATE Definition Chemical name Calcium sorbate Calcium salts of trans, trans-2,4-hexadienoic acid Einecs 231-321-6 Chemical formula C12H14O4Ca Molecular weight 262,32 Assay Content not less than 98 % on the dried basis Description Fine white crystalline powder not showing any change in colour after heating at 105 °C for 90 minutes Identification A. Melting range of sorbic acid isolated by acidification and not recrystallized 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator B. Positive tests for calcium and for double bonds Purity Loss on drying Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator Aldehydes Not more than 0,1 % (as formaldehyde) Fluoride Not more than 10 mg/kg Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 210 BENZOIC ACID Definition Chemical name Benzoic acid Benzenecarboxylic acid Phenylcarboxylic acid Einecs 200-618-2 Chemical formula C7H6O2 1996L0077 — EN — 29.12.1998 — 001.001 — 6 !B Molecular weight 122,12 Assay Content not less than 99,5 % on the anhydrous basis Description White crystalline powder Identification A. Melting range 121,5 °C to 123,5 °C B. Positive sublimation test and test for benzoate Purity Loss on drying Not more than 0,5 % after drying for three hours over sulphuric acid pH About 4 (solution in water) Sulphated ash Not more than 0,05 % Chlorinated organic compounds Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid Readily oxidizable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required Readily carbonizable substances A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (1), 0,3 ml of ferric chloride TSC (2), 0,1 ml of copper sulphate TSC (3)and 4,4 ml of water Polycyclic acids On fractional acidification of a neutralized solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid Arsenic Not more than 3 mg/kg Lead Not more than 5 mg/kg Mercury Not more than 1 mg/kg Heavy metals (as Pb) Not more than 10 mg/kg E 211 SODIUM BENZOATE Definition Chemical name Sodium benzoate Sodium salt of benzenecarboxylic acid Sodium salt of phenylcarboxylic acid Einecs 208-534-8 Chemical formula C7H5O2Na Molecular weight 144,11 Assay Not less than 99 % of C7H5O2Na, after drying at 105 °C for four hours Description A white, almost odourless, crystalline powder or granules Identification A.
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